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510(k) K003545

NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE by Terang Nusa Sdn Bhd — Product Code LYY

K003545 is an FDA 510(k) premarket notification submitted by Terang Nusa Sdn Bhd for the device "NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE". The FDA issued a decision of Substantially Equivalent on Dec 21, 2000. The device falls under product code LYY (Latex Patient Examination Glove), a Class I device regulated under 21 CFR 880.6250. Terang Nusa Sdn Bhd has 25 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 21, 2000
Date Received
Nov 17, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Latex Patient Examination Glove
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type
510(k)

A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Other clearances by Terang Nusa Sdn Bhd

  • K170779 — Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50… (May 24, 2017)
  • K161932 — Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene… (Nov 28, 2016)
  • K153510 — Powder Free Polychloroprene Examination Glove Green (Mar 21, 2016)
  • K151392 — Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein… (Sep 18, 2015)
  • K140355 — SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT… (Nov 6, 2014)
  • K110698 — NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE (Dec 7, 2011)
  • K102230 — NUGARD NITILE GREY COLOR (Sep 10, 2010)
  • K102119 — SUR-G GLOV AND MAXITEX (Aug 27, 2010)
  • K083337 — NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES (Jan 27, 2009)
  • K052837 — SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA (Nov 21, 2005)

Other clearances for product code LYY

  • K250069 — Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and… (Apr 29, 2025)
  • K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White) (Sep 9, 2024)
  • K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with… (Jun 13, 2023)
  • K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) (Feb 22, 2023)
  • K222612 — Powder-Free Latex examination gloves (Nov 25, 2022)
  • K221667 — Non Sterile Powder Free Latex Examination Glove (Oct 28, 2022)
  • K222348 — JR MEDIC (Oct 27, 2022)
  • K221374 — Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) (Oct 26, 2022)
  • K222693 — Single-use medical latex examination gloves (LG100) (Sep 24, 2022)
  • K221648 — Iconic Latex Glove (Aug 25, 2022)

FDA data resources